Vitamin d DeficiencyETOL-ElderlyNCT05661006
ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults
A study testing Use of food supplement in people with Vitamin d Deficiency and Vitamin B 12 Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
Trial summary
The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional… Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin d Deficiency, Vitamin B 12 Deficiency, Protein Deficiency
- What is being tested?
- Use of food supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Feb 2020to 29 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subject Informed consent form (ICF) is singed
- Aged at least 65 at the time of the signature of ICF
- A body mass index lower than 32 kg/m2
- Willing to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the study
- Willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention)
Who cannot join
- Medical treatment with Vitamin D and/or Vitamin B12
- Supplementation with protein, vitamin D and/or vitamin B12 during least 2 months
- Known drug and/or alcohol abuse
- Known lactose/gluten intolerances/food allergies
- Inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal
- Have chronic bowel disease (ulcerative colitis, Chron's disease, stomach or duodenal ulcer, chronic inflammation of the stomach or duodenum)
Show all 16Show fewer
- Have acute gastrointestinal infection with vomiting and / or diarrhea
- Have planned general anaesthesia or colonoscopy at the time of the study
- Have malabsorption syndrome
- Less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
- Have stomach or bowel resection
- Do not have neat and functional teeth
- Take regular or occasional laxative products
- Use antacids (Rupurut / Rutacid / Talcit)
- Mental incapacity that precludes adequate understanding or cooperation
- Participation in another investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults
The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.
Read the detailed description
The main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. The study should provide answers to the following main questions: (1) Is regular use of investigated product beneficial for improving serum vitamin D levels in elderly population? (2) Is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) Is regular use of investigated product beneficial for improving vitamin B12 status in elderly population?
- Being tested
- Use of food supplement, Use of placebo food supplement
- Medical subject headings
- Vitamin D Deficiency, Vitamin B 12 Deficiency, Protein Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of food supplementDietary supplement
On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute).
In the following days: continuation of consumption of test product once per day until end of the intervention. Subjects are recording daily consumption of the product. Intervention diet recording during last week of intervention (days 49-56): 3x24h dietary records (two days during weekday, one weekend day).
Intervention end on day 56 ±3 (fasted condition):
Measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP Measuring body weight \& height Collecting data regarding the palatability of the product
Use of placebo food supplementDietary supplement
On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Subjects taking control product Receives: Dietary Supplement: Use of placebo food supplement |
| Active group | Experimental | Subjects taking active product Receives: Dietary Supplement: Use of food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum vitamin D levels will be determined
Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.
Measured: 56 days
Secondary outcomes (3)
Change in dietary protein intake will be determined
Dietary protein intake will be estimated before and after the intervention for each individual, using 3x24h food records.
Measured: 56 days
Change in serum vitamin B12 levels will be determined
Serum level of vitamin B12 will be measured before and after the intervention for each individual.
Measured: 56 days
Malnutrition at baseline
Risks for malnutritition at baseline will be assessed using dietary records (3x24h food record: energy, protein and plasma concentration of 25-OH-D and vitamin B12.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start20 Feb 2020
- Primary completion5 May 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin d DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized, parallel, double-blind, placebo-controlled study included healthy elderly adults (age \> 65 years) who tested study products. On screening visit, participants underwent measuring of body weight \& height, and blood collection for measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP. Duration of study intervention for individual participant 56 ± 3 days, with one week pre-intervention monitoring of food intake (3x 24-h dietary records). On day 1 of the intervention period, participants were randomised in a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- Vizera d.o.o., Frutarom Etol d.o.o., European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Mojca Miholič, MD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661006
- Sponsor's protocol ID
- 2020/1-ET-SK
- Acronym
- ETOL-Elderly
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults
- ClinicalTrials.gov ID
- NCT05661006
- Acronym / sponsor ID
- ETOL-Elderly / 2020/1-ET-SK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- Vizera d.o.o., Frutarom Etol d.o.o., European Regional Development Fund
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.
Detailed description
The main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. The study should provide answers to the following main questions: (1) Is regular use of investigated product beneficial for improving serum vitamin D levels in elderly population? (2) Is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) Is regular use of investigated product beneficial for improving vitamin B12 status in elderly population?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a randomized, parallel, double-blind, placebo-controlled study included healthy elderly adults (age > 65 years) who tested study products. On screening visit, participants underwent measuring of body weight \& height, and blood collection for measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP. Duration of study intervention for individual participant 56 ± 3 days, with one week pre-intervention monitoring of food intake (3x 24-h dietary records). On day 1 of the intervention period, participants were randomised in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: Use of placebo food supplementSubjects taking control product |
| Active group | Experimental | Dietary Supplement: Use of food supplementSubjects taking active product |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Subject Informed consent form (ICF) is singed
- Aged at least 65 at the time of the signature of ICF
- A body mass index lower than 32 kg/m2
- Willing to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the study
- Willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention)
Key exclusion criteria (16 listed)
- Medical treatment with Vitamin D and/or Vitamin B12
- Supplementation with protein, vitamin D and/or vitamin B12 during least 2 months
- Known drug and/or alcohol abuse
- Known lactose/gluten intolerances/food allergies
- Inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of food supplementOn day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end of the intervention. Subjects are recording daily consumption of the product. Intervention diet recording during last week of intervention (days 49-56): 3x24h dietary records (two days during weekday, one weekend day). Intervention end on day 56 ±3 (fasted condition): Measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP Measuring body weight \& height Collecting data regarding the palatability of the product | Dietary supplement | Active group |
| Use of placebo food supplementOn day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end | Dietary supplement | Control group |
Primary outcome
Change in serum vitamin D levels will be determined
Time frame: 56 days
Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.
3 secondary outcomes
Change in dietary protein intake will be determined
Time frame: 56 days
Change in serum vitamin B12 levels will be determined
Time frame: 56 days
Malnutrition at baseline
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mojca Miholič, MD principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of food supplement in people with Vitamin d Deficiency and Vitamin B 12 Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum vitamin D levels will be determined (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.